In the final days of 2022, the long-awaited Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law, marking the first major amendment to the federal framework governing cosmetics since 1938.
What are the most significant changes that the new law will bring to the cosmetics industry?
MoCRA significantly expands FDA oversight of the cosmetics industry. Once fully implemented, MoCRA will require:
- Facility registration;
- Product listing;
- Adherence to current Good Manufacturing Practices (“CGMPs”);
- Maintenance of records of adverse events;
- Reporting of serious adverse event reports to FDA;
- Records supporting substantiation of safety for each cosmetic product;
- Potential, minor label modifications to include contact information for adverse event reporting; and
- Labeling of fragrance allergens.
The law also grants FDA the authority to initiate mandatory recalls and to suspend facility registration if warranted.
